A study to investigate the efficacy and safety of subcutaneous lunsekimig (SAR443765) compared with placebo in adult participants with moderate-to-severe atopic dermatitis

JRCT ID: jRCT2031240665

Registered date:06/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dermatitis atopic
• Date of first enrollment: 12/02/2025
• Target sample size: 144
• Countries of recruitment: TBD,Japan
• Study type: Interventional

Intervention(s)

Drug: Lunsekimig (SAR443765)
Pharmaceutical form: Solution for injection in vial, Route of administration: subcutaneous (SC) injection
Drug: Placebo
Pharmaceutical form: Solution for injection in vial, Route of administration: SC injection

Study Arms:
- Experimental: Lunsekimig arm A
Participants will receive SC injection of lunsekimig dosing regimen A.
- Placebo Comparator: Placebo arm B
Participants will receive SC injection of matching placebo.
- Experimental: Lunsekimig arm C
Participants will receive SC injection of lunsekimig dosing regimen C.
- Placebo Comparator: Placebo arm D
Participants will receive SC injection of matching placebo.
- Experimental: Lunsekimig arm E
Participants will receive SC injection of lunsekimig dosing regimen E.
- Placebo Comparator: Placebo arm F
Participants will receive SC injection of matching placebo.

Outcome(s)

Primary Outcome

1. Percent change in EASI score from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

Secondary Outcome

1. Proportion of participants achieving EASI-75 at Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
EASI-75 is defined by reduction of EASI score by >=75% from baseline.
2. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) and a reduction from baseline of >=2 points at Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The vIGA-AD score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).
3. Proportion of participants with reduction (improvement) of >=4 in the weekly average of daily PP-NRS score from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The PP-NRS is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
4. Absolute change from baseline in EASI score at Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the primary outcome-1 for "EASI".
5. Percent change from baseline in EASI score throughout the study
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the primary outcome-1 for "EASI".
6. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the secondary outcome-2 for "vIGA-AD".
7. Proportion of participants with a response of vIGA-AD 0 or 1 and a reduction from baseline of >=2 points throughout the study
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the secondary outcome-2 for "vIGA-AD".
8. Percent change in the weekly average of daily PP-NRS scores from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the secondary outcome-3 for "PP-NRS".
9. Percent change in the weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) score from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The SD-NRS is a validated single item 0-10 numerical rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of AD' and 10 being 'I did not sleep at all due to the symptoms of AD'.
10. Percent change in the weekly average of daily Skin Pain Numeric Rating Scale (SP-NRS) score from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The SP-NRS is a whole number scale ranging from 0 to 10 with a 24-hour recall period, with 0 = no pain and 10 = worst possible pain imaginable. The threshold for determining clinically meaningful change is >= 4-point change in the weekly average SP-NRS.
11. Change in percent BSA affected by AD from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The BSA affected by AD will be assessed in 4 body regions: head/neck, trunk (including the genitals), upper extremities, and lower extremities (including the buttocks). Each body region should be evaluated from 0 to 100%. The percentage of the affected area will be multiplied by the proportion of that body region to the whole body.
12. Proportion of participants achieving EASI-50 at Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
EASI-50 is defined by reduction of EASI score by >=50% from baseline.
13. Proportion of participants achieving EASI-90 at Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
EASI-90 is defined by reduction of EASI score by >=90% from baseline.
14. Proportion of participants with improvement (reduction) of >=4 points in the weekly average of daily PP-NRS scores from baseline throughout the study
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the secondary outcome-3 for "PP-NRS".
15. Proportion of participants with improvement (reduction) of >=4 points in the weekly average of daily SD-NRS scores from baseline to Week 24, in participants with a baseline weekly average of daily SD-NRS scores of >=4 points
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the secondary outcome-9 for "SD-NRS".
16. Proportion of participants with improvement (reduction) of >=4 points in the weekly average of daily SP-NRS scores from baseline to Week 24, in participants with a baseline weekly average of daily SP-NRS scores of >=4 points
[Time Frame: From Baseline throughout the study, up to Week 24]
Refer to the secondary outcome-10 for "SP-NRS".
17. Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The SCORAD Index is a validated clinical tool that was developed to standardize the evaluation of the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
18. Proportion of participants with an improvement of >=4 points in Dermatology Life Quality Index (DLQI) score from baseline to Week 24 and throughout the study
[Time Frame: From Baseline throughout the study, up to Week 24]
The DLQI is a 10-item dermatology specific health-related quality of life (HRQoL) questionnaire. The total score is correlated to the detrimental effect of AD on quality of life (QoL) and ranges from 0 to 30, with a higher score indicating a poorer QoL.
19. Percent change in DLQI score from baseline to Week 24 and throughout the study
[Time Frame: From Baseline throughout the study, up to Week 24]
The DLQI is a 10-item dermatology specific HRQoL instrument and is a simple, validated, participant-completed questionnaire covering the participant's previous week (ie, past 7 days). The DLQI ranges from 0 to 30.
20. Percent change in Patient Oriented Eczema Measure (POEM) score from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms. The total score is correlated to eczema severity with 0 (absent disease) to 28 (very severe).
21. Percent change in Hospital Anxiety and Depression Scale (HADS) from baseline to Week 24
[Time Frame: From Baseline throughout the study, up to Week 24]
The HADS is a 14-item PRO questionnaire used to assess states of anxiety and depression over the past week with two subscales. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
22. Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study
[Time Frame: From Baseline throughout the study, up to Week 32]
23. Serum concentrations of lunsekimig throughout the study
[Time Frame: From Baseline throughout the study, up to Week 32]
24. Serum concentrations of lunsekimig in the PK/PD subgroup throughout the study
[Time Frame: From Baseline throughout the study, up to Week 32]
25. Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs)
[Time Frame: From Baseline throughout the study, up to Week 32]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
- Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1).
- Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments.
- Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1).
- Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
- AD involvement of 10% or more of Body Surface Area (BSA) at baseline (Day 1).
- Weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score of >=4 at baseline (Day 1).
- Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
- Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
- Known history of, or suspected, significant current immunosuppression.
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Information

• Primary Sponsor: Obara Kentaro
• Secondary ID(s): NCT06790121,2024-511549-20